Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA

Sánchez, Victoria; Hall, Deborah A.; Millar, Bonnie; Escabi, Celia; Sharman, Alice; Watson, Jeannette; Thasma, Sornaraja; Harris, Peter Q.

doi:10.1080/14992027.2018.1425002

Cited by 11 publications

(6 citation statements)

References 23 publications

(24 reference statements)

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“…As previously described in the published protocol paper (41), study participants were recruited to the clinical trial using media advertising and directed to an online eligibility assessment. Eligibility was initially assessed through a set of general prescreening questions to manage the large number of candidates expected to respond to the advertising (48). As anticipated, a substantial number of candidates (7627) registered their interest in the trial.…”

Section: Characteristics and Summary Of Study Participantsmentioning

confidence: 99%

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

et al. 2020

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Tinnitus is a phantom auditory perception coded in the brain that can be bothersome or debilitating, affecting 10 to 15% of the population. Currently, there is no clinically recommended drug or device treatment for this major health condition. Animal research has revealed that sound paired with electrical somatosensory stimulation can drive extensive plasticity within the brain for tinnitus treatment. To investigate this bimodal neuromodulation approach in humans, we evaluated a noninvasive device that delivers sound to the ears and electrical stimulation to the tongue in a randomized, double-blinded, exploratory study that enrolled 326 adults with chronic subjective tinnitus. Participants were randomized into three parallel arms with different stimulation settings. Clinical outcomes were evaluated over a 12-week treatment period and a 12-month posttreatment phase. For the primary endpoints, participants achieved a statistically significant reduction in tinnitus symptom severity at the end of treatment based on two commonly used outcome measures, Tinnitus Handicap Inventory (Cohen’s d effect size: −0.87 to −0.92 across arms; P < 0.001) and Tinnitus Functional Index (−0.77 to −0.87; P < 0.001). Therapeutic improvements continued for 12 months after treatment for specific bimodal stimulation settings, which had not previously been demonstrated in a large cohort for a tinnitus intervention. The treatment also achieved high compliance and satisfaction rates with no treatment-related serious adverse events. These positive therapeutic and long-term results motivate further clinical trials toward establishing bimodal neuromodulation as a clinically recommended device treatment for tinnitus.

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Section: Characteristics and Summary Of Study Participantsmentioning

confidence: 99%

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

et al. 2020

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“…In TENT-A2, study participants were recruited to the clinical trial using radio advertising and directed to an online eligibility assessment. Eligibility was initially assessed through a set of general pre-screening questions to manage the large number of candidates expected to respond to the advertising 22 . Of these potential participants, 462 signed an informed consent and attended a clinical screening visit.…”

Section: Methodsmentioning

confidence: 99%

Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial

Conlon

Hamilton

Meade

et al. 2022

Sci Rep

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More than 10% of the population suffers from tinnitus, which is a phantom auditory condition that is coded within the brain. A new neuromodulation approach to treat tinnitus has emerged that combines sound with electrical stimulation of somatosensory pathways, supported by multiple animal studies demonstrating that bimodal stimulation can elicit extensive neural plasticity within the auditory brain. More recently, in a large-scale clinical trial, bimodal neuromodulation combining sound and tongue stimulation drove significant reductions in tinnitus symptom severity during the first 6 weeks of treatment, followed by diminishing improvements during the second 6 weeks of treatment. The primary objective of the large-scale randomized and double-blinded study presented in this paper was to determine if background wideband noise as used in the previous clinical trial was necessary for bimodal treatment efficacy. An additional objective was to determine if adjusting the parameter settings after 6 weeks of treatment could overcome treatment habituation effects observed in the previous study. The primary endpoint at 6-weeks involved within-arm and between-arm comparisons for two treatment arms with different bimodal neuromodulation settings based on two widely used and validated outcome instruments, Tinnitus Handicap Inventory and Tinnitus Functional Index. Both treatment arms exhibited a statistically significant reduction in tinnitus symptoms during the first 6-weeks, which was further reduced significantly during the second 6-weeks by changing the parameter settings (Cohen’s d effect size for full treatment period per arm and outcome measure ranged from − 0.7 to − 1.4). There were no significant differences between arms, in which tongue stimulation combined with only pure tones and without background wideband noise was sufficient to reduce tinnitus symptoms. These therapeutic effects were sustained up to 12 months after the treatment ended. The study included two additional exploratory arms, including one arm that presented only sound stimuli during the first 6 weeks of treatment and bimodal stimulation in the second 6 weeks of treatment. This arm revealed the criticality of combining tongue stimulation with sound for treatment efficacy. Overall, there were no treatment-related serious adverse events and a high compliance rate (83.8%) with 70.3% of participants indicating benefit. The discovery that adjusting stimulation parameters overcomes previously observed treatment habituation can be used to drive greater therapeutic effects and opens up new opportunities for optimizing stimuli and enhancing clinical outcomes for tinnitus patients with bimodal neuromodulation.

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“…Without a standard care pathway across the UK for the management of tinnitus, we have chosen to undertake a feasibility trial to inform the design of a future definitive RCT to assess the effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss. We anticipate that this trial might present a number of methodological challenges as there have been relatively few previous large-scale RCTs engaging audiologists within UK audiology clinics; at least one largescale RCT (of an investigational medicinal product) has reported the need to adjust procedures, recruitment and screening methods to meet targets [36]. Work still needs to be undertaken to help audiology clinics embed highquality trials alongside their clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial)

Haines

White

Meakin

et al. 2020

Pilot Feasibility Stud

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Background: The most common management strategy for tinnitus provided in the UK audiology clinics is education and advice. This may also be combined with some form of sound therapy (e.g. digital hearing aids). While education and advice is generally provided by all clinics, there is a marked variability in provision of hearing aids that depends very much on clinical decisions. A recent Cochrane review concluded a lack of evidence to support or refute hearing aid use as a routine intervention for people with tinnitus and hearing loss. This lack of evidence is reflected in the inconsistency of tinnitus management in the UK. The aim of the HUSH trial is to determine the feasibility of conducting a definitive randomised controlled trial (RCT) of the effectiveness and costeffectiveness of hearing aids for adults with tinnitus and hearing loss. Methods: This is a multicentre randomised controlled feasibility trial. Up to 100 adults, aged 18 and over, presenting to 5 UK audiology clinics with a complaint of tinnitus and measurable hearing loss are being randomised to receive either (i) education and advice (treatment as usual) or (ii) education and advice with digital hearing aids. Feasibility outcomes are being collected around recruitment, retention, patient and healthcare professional acceptability and clinical outcome assessment. Outcomes are being collected via postal questionnaire at 12 weeks post baseline. A nested interview study will supplement clinical and other outcome data, providing a detailed understanding of participants' and audiologists' experience of both tinnitus management and the research processes.

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Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA

Abstract: A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

Cited by 11 publications

References 23 publications

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial

Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial)

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